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Assessment of GRASP Medical Device to Improve Arm Coordination After Stroke

This study has been terminated.
(failure to recruit)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01134796
First Posted: June 2, 2010
Last Update Posted: December 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Nottingham
  Purpose
Assessment of a custom made grasp device in the rehabilitation of stroke victims.

Condition
Stroke

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of GRASP II Medical Device to Improve Arm Coordination After Stroke

Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • Time to grasp [ Time Frame: 3 sessions ]
    Primary outcome measures are: 1) The time elapsed between the start of grasp (when the finger breaks contact with the thumb) and the start of transport (when the wrist leaves the start position); and 2) The time elapsed between maximum aperture of the hand and peak deceleration of the wrist. Secondary outcome measures are: 1) movement duration, 2) time of maximum aperture expressed as % of movement duration, 3) time of peak deceleration expressed as % of movement duration, 4) amplitude of peak velocity of the wrist, 5) time of peak velocity, 6) time of peak velocity of the wrist expressed as % movement duration, 7) size of maximum aperture, 8) time to close hand from time of maximum aperture, 9) distance to target at time of maximum aperture.


Enrollment: 10
Study Start Date: September 2010
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Stroke pateints and healthy volunteers (controls)
Criteria

Inclusion Criteria:

  1. Damage to the following areas of the brain, all of which may be involved in coordination of reach to grasp confirmed by CT scan: parietal, cerebellar, internal capsule and basal ganglia,
  2. A score of 6 or more on the arm section of the Rivermead Motor Assessment (able to reach and pick up a tennis ball and release on thigh),
  3. Time between start of hand opening and start of hand transport > 60 ms (measured with GRASP).

Exclusion Criteria:

  1. Cognitive dysfunction which prevents understanding of the task,
  2. Severe concurrent medical problems that prevent repetitive reaching (including shoulder pain),
  3. A diagnosis of Parkinson's disease, or
  4. Lack of informed consent.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01134796


Sponsors and Collaborators
University of Nottingham
Investigators
Principal Investigator: Paulette Van Vliet University of Nottingham
  More Information

Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT01134796     History of Changes
Other Study ID Numbers: 09103
First Submitted: May 28, 2010
First Posted: June 2, 2010
Last Update Posted: December 3, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases